Catalog Number

ZDC4412F-NEOP

Brand Name

N/A

Version/Model Number

ZDC4412F-NEOP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080366,K080366

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

8bf9aa94-8504-4cd8-85c8-d563a3e4c3dc

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 12, 2018

Package DI Number

10607411940634

Quantity per Package

5

Contains DI Package

00607411940637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-